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Completed

NCT Number: NCT03467815

Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease

For patients admitted to the medical ward, it is usually difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Clinical Deterioration Disease Attributes Disease Progression Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.

Exclusion criteria

  • Patient expected not to cooperate.
  • Patient allergic to plaster, plastic or silicone.
  • Active therapy withdrawn

Treatment and study plan

Primary outcomes

  1. Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm

    Time frame: The patients are monitored for 4 days

    Hypoxemia: arterial oxygen saturation < 92 %

  2. Heart rate resulting in a single parameter score of 3 according to EWS algorithm

    Time frame: The patients are monitored for 4 days

    All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used:

    Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm

  3. Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm

    Time frame: The patients are monitored for 4 days

    Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min

  4. Blood pressure resulting in a single parameter score of 3 according to EWS algorithm

    Time frame: The patients are monitored for 4 days

    Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • Technical University of Denmark

Registry information

Official study title

Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - A Pilot Study

Acronym: WARD-COPD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2018
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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